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What kind of specimens do you accept?

Is a separate tube of blood required for each test?

No, only one tube of the required 3-5 ml of blood will be sufficient to perform multiple tests. Blood should be collected in an EDTA (purple top) or ACD (yellow top) tube.

I am drawing a specimen from an infant. What is the minimum amount of blood required?

We require a minimum of 1 ml of whole blood in an EDTA (purple top) or ACD (yellow top) tube.

What is the stability of a blood specimen?

If the blood is stored at room temperature, it is good for up to 48 hours. If the blood is refrigerated, it is good for up to one week. Do not
freeze the blood.

Does PreventionGenetics accept DNA extracted in other laboratories?

Yes, PreventionGenetics accepts purified DNA. We require a minimum of 20 &microg of DNA at a concentration of at least 50 &microg/ml for NextGen Sequencing Tests and 15 &microg of DNA
at a concentration of at least 20 &microg/ml for Sanger Tests . For Sanger tests involving the sequencing of more than three genes, please send an additional 5 &microg per gene.
We require that concentration, composition of the solute and identity of the specimen be clearly indicated on the DNA tube.
PreventionGenetics does not accept products of whole genome amplification or other amplification products.

What are the requirements for a prenatal specimen?

We accept purified fetal DNA or cultured fetal cells. For prenatal testing of known familial mutations we require 2 T25 flasks of confluent cells or 5 &microg of purified DNA.
For prenatal NextGen tests contact us for minimum requirements. For prenatal Sanger tests of whole genes or multiple genes, a minimum of 4 confluent T25 flasks or 10 &microg of DNA is
required. Cell cultures are only accepted Monday-Thursday. Advance notification of a prenatal specimen is required.
See our Prenatal Testing Guidelines for more information.
A signed Health Care Provider's Statement
is required for all prenatal tests. We are unable to offer prenatal testing for Deletion/duplication studies via aCGH at this time.

What paperwork do I need to include with each specimen?

The first 3 pages of our Test Requisition Form must accompany each specimen.
The Test Requisition Form must be filled in completely. Incomplete paperwork will delay testing.

Shipping

How do I send a specimen?

Blood specimens should be shipped in a crushproof, insulated container. Whole blood and cell cultures are usually sent by overnight courier.
Purified DNA may be sent by a slower mechanism. All specimens should be accompanied by the first three pages of our
Test Requisition Form.

Where do I ship a specimen?

Do you accept Saturday or Holiday deliveries?

We accept whole blood and DNA Monday-Saturday. Cell cultures are only accepted Monday-Thursday, and we prefer to be notified in advance of their arrival. PreventionGenetics is closed
on major Holidays.

Can I ship specimens by regular postal mail?

We do not recommend shipping blood specimens or cell cultures by mail. They should be shipped by overnight express. Purified DNA may be shipped through postal mail.

Does PreventionGenetics pay for shipping?

Yes, we are pleased to offer clinical testing kits for our national clients. If you would like to order clinical testing kits, please use our
electronic order form. We are unable to pay for shipping for international clients at this time.

Turnaround Times

How long do results take?

Do you have a STAT option for ordering a test?

Yes, we offer a STAT option for Sanger sequencing and gene-centric aCGH. The great majority of STAT tests are completed within 8 calendar days. If we are unable to complete STAT Sanger sequencing requests within 10 days, STAT surcharge (25%) will be waived. We are happy to attempt STAT del/dup requests. We will only charge STAT surcharge if testing is completed within 10 days. Requests for multiple gene tests are sequenced concurrently in STAT tests, rather than sequentially (our standard approach). NextGen panels and Chromosomal Microarray are not currently available to be ordered STAT. For urgent aCGH, CMA, or NextGen Sequencing Panel requests, please contact us

How long do prenatal tests take?

The great majority of targeted prenatal tests are completed within 8-10 days. We prioritize all testing related to ongoing pregnancies in order to get the results out as quickly as possible. Please alert us if you order testing for situations of extreme clinical urgency.

What is your procedure to add-on another test for a patient who was tested previously at PreventionGenetics?

Do I have to send another specimen sample if I am adding on a test?

Usually not. PreventionGenetics retains unused DNA from previous tests. If a blood specimen was originally sent, we nearly always have sufficient DNA to perform additional tests.
If a limited amount of purified DNA was originally sent, then a second specimen will often be required.

Billing

What is your tax identification number?

PreventionGenetics LLC Tax Identification Number is 83 0343803.

Does Preventiongenetics accept insurance?

PreventionGenetics will file an insurance claim on behalf of the patient with any commercial insurance company.

What is necessary for PreventionGenetics to bill insurance?

Page 4 of the TRF indicates the information needed for insurance billing. This section must be completed in its entirety before testing can begin. This includes additional information
such as pre-authorization information, pertinent medical record information, and/or a letter of medical necessity.

If insurance has been verified and preauthorization obtained, why would my patient receive an invoice for charges (partial or total)?

Preauthorization does not guarantee payment. Insurance companies determine payment and what charges will be billed to the patient after a medical claim is filed.

As a friendly reminder that the test has been completed and there is the possibility of some financial obligation from the patient, an invoice will be mailed to the patient after
testing is complete. The invoice will indicate that an insurance claim has been filed and no payment is due at this time. A monthly statement indicating an insurance claim is in process
will also be mailed to the patient. No payment will be required from the patient until the insurance claim has been processed and closed. Once insurance payment has been received, the
monthly statement will indicate the remaining balance and note that the remaining amount is now due from the patient.

The patient is responsible for notifying PreventionGenetics of the status of the explanation of benefits (EOB) and remitting any funds received directly from the insurance company to
PreventionGenetics

The patient is responsible for any portion of the test fee not covered by the insurance company for any reason including, but not limited to, co-payments, co-insurance, unmet
deductibles, or non-covered services.

How can patients find out how much their insurance will cover?

While preauthorization does not guarantee payment, PreventionGenetics can assist with pre-verification or pre-authorization of insurance coverage. For assistance please complete the
insurance pre-verification/pre-authorization form found on our website or call our insurance specialists at 715-387-0484 extension 162 or 185.

Where are the specific CPT codes and prices for the test I'm ordering?

A spreadsheet containing CPT Codes and prices for our tests can be found here.

Does PreventionGenetics participate in any Medicare or Medicaid plans?

We are a contracted provider for Medicare and Wisconsin Medicaid. At this time we do not accept any other state's Medicaid.

The patient must meet Medicare criteria for genetic testing in order for the services provided to be considered covered and reimbursable by Medicare. We do require Medicare patients
to sign a completed advance beneficiary notice (ABN) in advance of testing to acknowledge financial responsibility should the testing not meet Medicare criteria for covered service.

Is PreventionGenetics Contracted with private insurance companies?

We are a contracted provider for Security Health Plan and HealthChoice (State of Oklahoma). We are also a contracted provider for Wisconsin Medicaid.

Does PreventionGenetics bill institutions?

Yes, PreventionGenetics will invoice the institution or provider directly for the total test fee once the report has been sent to the ordering healthcare provider.

Does PreventionGenetics offer patient self-pay?

Yes, we will bill the patient directly. The individual accepting financial responsibility for the test fees must sign the acknowledgement statement on the Test Requisition Form. The
responsible billing party must be at least 18 years old.

Does PreventionGenetics require pre payment for self-pay testing?

No. We do not bill for the test until testing is complete. We do not require a credit card to be on file, however, having a credit card authorization on file allows for easy payment
processing once the test has been completed. PreventionGenetics accepts Visa, MasterCard, and Discover. We can also accept payments by bank wire transfer, Automatic Clearning House (ACH),
or check.

Does PreventionGenetics offer different pricelists for different payment types?

Regardless of the nature of payment or payer, we strive to provide the lowest prices in the market and therefore, our prices do not vary for different payment options. Our prices are
transparent and openly published on our website. We offer three (3) convenient payment options for testing services: we can bill the ordering institution/provider directly
(institutional billing), we can bill the patient directly (self-pay), or we can bill the patient's commercial insurance company (insurance billing).

What Date of Service does PreventionGenetics use?

Date of service (DOS) on the invoice will be the accession date. If the DOS must reflect the date that testing is started (rather than accession date) please contact our billing team
to make arrangements.

What are the payment terms?

Payment is due 30 days from the date of the invoice, or 30 days from the date the insurance claim closes. Please contact our billing team to discuss payment plans if necessary.

What happens if we cancel a test?

Tests that are cancelled while in progress will be billed for the amount of work completed up to the point of cancellation. If you need to cancel a test, please contact our client
services department.

Test Information

Does PreventionGenetics provide detailed information for each test?

Yes, a detailed Test Description for each test is freely and easily available from our web site. Just search a test to begin.

Can we order testing for a specific mutation, or do we have to order the entire gene?

We offer single (Test #100, $250), double (Test #200, $370) or triple (Test #300, $440) exon sequencing for any of the genes on our test menu. These tests are typically performed
for relatives of the probands or for confirmation of test results from other labs. Please specify the mutation fully in the comments section at the bottom of page 1 of the
Targeted Variant Test Requisition Form.

Do you offer Deletion/Duplication testing?

Yes, PreventionGenetics offers a custom designed, high probe density, gene-centric aCGH test(our Test #600) which targets essentially
all of the genes on our test menu. Mutation fully in the comments section at the bottom of page 1 of the
Test Requisition Form.

Do you offer free family testing for Variants of Unknown Significance?

We offer free testing for variants of unknown significance in up to two family members of probands who were tested at PreventionGenetics.Free testing for deletion/duplications of
unknown significance discovered by aCGH will be available for family members of the proband only if we are able to test the del/dup by PCR or qPCR.Please complete our
Targeted Variant Test
Requisition Form and mark the &quotNo Charge&quot box on the Test Selection box on page 1.

Do you require positive control samples for targeted mutations?

If the family member was tested at an outside laboratory, we recommend that you submit a sample from that individual to serve as a positive control. The positive control sample will be
tested free of charge and no report will be provided. If a positive control is not provided, negative results will carry a limitation stating that PreventionGenetics did not have the
opportunity to verify that we can detect the variant in this family.

If I only want to order a single gene, but it's only available on a NextGen Sequencing panel, can I order it individually?

Yes, if we understand that there may be valid clinic reasons to order single gene testing for a gene that we currently only offer on multi-gene NextGen Sequencing panel. In these
situations the price will be $1290 as long as you indicate &quotInterpret only XXXX gene&quot on the Test Requisition Form. In the event that more than 1 gene is desired (but not the full panel), please contact us for customized pricing details.

Can I order a NextGen Sequencing panel update?

If our NextGen Sequencing panel is updated to offer additional genes, we will offer a panel update for a charge of $1290. Please contact us to confirm that
we have adequate DNA remaining, and then complete our Add-On Test Requisition Form specifying NextGen Sequencing panel of interest and &quotUpdate&quot. The interpretation will include only the genes that
have not been previously analyzed. CPT codes for newly added genes apply.

If I order a smaller NextGen Sequencing panel that is negative, can I reflex to a larger NextGen Sequencing panel?

Yes, for many of our NextGen Sequencing panels we offer smaller, more focused disease-specific panels and also a broader, more comprehensive panel. Please
contact us to discuss your situation.

Certificates & Licenses

Is PreventionGenetics CLIA accredited?

Yes, identification number 52D2065132, expires April 1st, 2018. The certificate is posted on our website.

Is PreventionGenetics CAP accredited?

Is PreventionGenetics ISO 15189 accredited?

Yes, we are ISO 15189 accredited. Our certification number is 3950.01 and is posted on our website.

Do you hold any other state licenses?

Yes, PreventionGenetics is currently licensed by the states of New York, California, Maryland, Florida and Rhode Island. The
certificates are posted on our web site. For New York approved tests and more details please see our NY Landing Page